Monday, February 06, 2023 11:21:55 PM
July 15, 2022.-- We concluded that the validation of certain elements of our Manufacturing process are necessary to assemble a complete portfolio of information that the FDA can then use to complete its review our PMA application. We will work Expeditiously with our manufacturing partner in the coming week to accomplish these remaining Tasks..( IMO- this piece for me says last but not least, we are on the last leg:)
SEPT. 06, 2022-- it is anticipated that the completion of the Audit process, established and inspection of gauze production, drafting of associated documentation, and testing of product to ensure conformance with Previouse product specification will be completed within 60 days.
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